Uli Hack­sell, Cere­cor

Just a few days af­ter Cere­cor was pum­meled $CERC by the news that its lead de­pres­sion drug, CERC-301, failed a mid-stage study, the mi­cro­cap com­pa­ny has been forced to ad­mit that its top drug over­all flopped in a Phase II for nico­tine with­draw­al.

CERC-501, re­cent­ly the sub­ject of some con­sid­er­able mar­ket buzz af­ter a sim­i­lar treat­ment from Alk­er­mes scored pos­i­tive da­ta in two late-stage tri­als, failed the tri­al of 71 heavy smok­ers. But the biotech now plans to sol­dier on in ma­jor de­pres­sion, look­ing to see if it can make progress in a field lit­tered with the corpses of dead drug pro­grams.

Cere­cor’s al­ready bat­tered shares plunged 43%, drop­ping in­to pen­ny stock ter­ri­to­ry in pre-mar­ket trad­ing.

“There is pre­clin­i­cal and re­cent clin­i­cal ev­i­dence that strong­ly sup­port the po­ten­tial use of oth­er KOR an­tag­o­nists as nov­el med­i­cines for the treat­ment of mood- and stress-re­lat­ed con­di­tions, such as MDD and anx­i­ety dis­or­ders. We be­lieve that our KOR an­tag­o­nist, CERC-501, has sim­i­lar po­ten­tial,” added Dr. Uli Hack­sell, Pres­i­dent and Chief Ex­ec­u­tive Of­fi­cer at Cere­cor. “We will now turn our fo­cus to prepar­ing CERC-501 for a Phase 2/3 clin­i­cal tri­al as an ad­junc­tive treat­ment of MDD in pa­tients with an in­ad­e­quate re­sponse to stan­dard an­ti­de­pres­sant ther­a­pies. We hope to ini­ti­ate this tri­al in the sec­ond half of 2017.”

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

GlaxoSmithKline is leaving the deep dark woods and its viruses behind.

GSK has agreed to divest its vaccines for rabies, RabAvert, and tick-born encephalitis vaccine, Encepur, to Bavarian Nordic, part of the company’s broader efforts to narrow its pipeline and focus on oncology and immunology.

The deal is worth up to nearly $1.1 billion, with a $336 million upfront payment. GSK acquired the vaccines from Novartis as part of an exchange for their late-stage oncology programs in 2015 under former chief Sir Andrew Witty.

While the FDA recently spurned an application to allow AstraZeneca’s blockbuster drug Farxiga for type 1 diabetes that cannot be controlled by insulin, citing safety concerns — the US regulator has endorsed the use of the SGLT2 treatment to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes and established cardiovascular disease or multiple CV risk factors.

Alexion has racked up a second approval for Ultomiris, the successor therapy to Soliris, as its mainstay blockbuster therapy faces a patent review process that could drastically shorten its patent exclusivity.

The FDA OK for atypical hemolytic uremic syndrome (aHUS) on Friday was widely expected after Alexion posted a full slate of positive Phase III data in January. But regulators also flagged concerns about serious meningococcal infections, slapping a black box warning on the label and mandating a REMS.

Months ago, Foamix leaned on its biggest shareholders — Perceptive Advisors and OrbiMed — to financially grease its wheels, ahead of the FDA decision date for its acne therapy. On Friday, that approval came in — and the topical formulation of the antibiotic minocycline is set for a January launch.

The therapy, Amzeeq (formerly known as FMX101), was approved to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 and older.

The rising popularity of CD47 has propelled the “don’t-eat-me” signal to household name status in the immuno-oncology world: By blocking that protein, the theory goes, one can stop cancer cells from fooling macrophages. But just as PD-(L)1 merely represents the most fruitful of all checkpoints regulating T cells, Verseau Therapeutics is convinced that CD47 is one of many regulators one can modulate to stir up or tame the immune system.